vitamin d treatment and hypogonadism in men

Conditions: Hypogonadism

Summary: low total testosterone (tt) is present in about 30% of men aged \>60 years and in up to 7% of younger men. male hypogonadism is associated with metabolic and cardiovascular diseases as well as with increased mortality. there is evidence showing a relationship of tt with vitamin d in men. we aim at evaluating the effect of vitamin d supplementation on tt and metabolic parameters in hypogonadal men. we will study the effects of 20,000 iu vitamin d weekly in a 12 wk randomized, double-blind, placebo-controlled trial in 100 men with tt \<3.0 ng/ml and 25-hydroxyvitamin d (25(oh)d) \<30 ng/ml (patients) as well as in 100 men with tt ≥3.0 ng/ml and 25(oh)d \<30 ng/ml (controls). vitamin d supplementation might be a safe therapeutic approach improving tt levels as well as metabolic parameters in hypogonadal men. further the effects of vitamin d on androgens will be evaluated in eugonadal men.


Eligibility criteria:
hypogonadal men: inclusion criteria: * tt levels below 3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1) * 25(oh)d levels below 30 ng/ml (measured at the baseline visit) * male, age of ≥ 18 and \<70 years * written informed consent before entered into study exclusion criteria: * - hypercalcemia defined as a serum calcium \> 2,7 mmol/l * oral or transdermal testosterone supplementation in the last 2 months before entering the study * im testosterone supplementation 6 months before entering the study * regular intake of vitamin d supplements before study entry * men with chronic diseases (such as diabetes mellitus, thyroid disease, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin d intake or very sensitive to vitamin d intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, mb wegener, vasculitis, inflammatory bowel disease * intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,...) in the last 3 months before study entry * psa \>4 ng/ml (or \>3 ng/ml in men at high risk for prostate cancer) (see state of the art) * palpable prostate nodule or induration * hematocrit \>50% * untreated severe obstructive sleep apnea * severe lower urinary tract symptoms * uncontrolled or poorly controlled heart failure * a history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. klinefelter syndrome) eugonadal men: inclusion criteria: * tt levels ≥3.0 ng/ml (measured at the baseline visit and confirmed at study visit 1) * 25(oh)d levels below 30 ng/ml (measured at the baseline visit) * male, age of ≥ 18 and \<70 years * written informed consent before entered into study exclusion criteria: * hypercalcemia defined as a serum calcium \> 2,7 mmol/l * oral or transdermal testosterone supplementation in the last 2 months before entering the study * im testosterone supplementation 6 months before entering the study * regular intake of vitamin d supplements before study entry * men with chronic diseases (such as diabetes mellitus, endocrine disturbances in need of treatment (except hypogonadism), or diseases known to interfere with vitamin d intake or very sensitive to vitamin d intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, mb wegener, vasculitis, inflammatory bowel disease * intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, insulin, glucocorticoids,...) in the last 3 months before study entry * psa \>4 ng/ml (or \>3 ng/ml in men at high risk for prostate cancer) (see state of the art) * palpable prostate nodule or induration * hematocrit \>50% * untreated severe obstructive sleep apnea * severe lower urinary tract symptoms * uncontrolled or poorly controlled heart failure * a history of prostate cancer, breast cancer, orchidectomy, chromosomal disorders (e.g. klinefelter)

Keywords: vitamin d hypogonadism testosterone intervention